NCT06963801

DBT-P Treatment Study

Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate. The main questions it aims to answer are: * Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope? * How is a participant's heart rate affected by their ability to control their emotions during pregnancy? Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate. Participants will: * Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy. * Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions. * Have their heart rate taken. * If assigned to the investigational group, they will complete weekly remote emotion regulation skills groups for 10 weeks and complete daily diary cards that ask about mood and any thoughts of self-harm. * Optional Element: Complete a 20-30min infant neurobehavior exam (NNNS exam) after delivery.

Detailed description

The investigators' observational research with mothers with emotion dysregulation and their infants shows that poor emotion regulation skill use is a mechanism that likely confers risk for self-injurious thoughts and behaviors, depression, and anxiety in the mother and neurobehavioral and co-regulatory challenges in the infant. Emotion dysregulation is an impairing, early-emerging, transdiagnostic vulnerability factor that has intergenerational implications. Treatments have been developed for non-pregnant adults with emotion dysregulation but these are costly, time-intensive, and do not address the unique needs of pregnant people, highlighting an unmet therapeutic need. Through this innovative intervention, researchers will test whether targeting emotion regulation skills use during pregnancy will both improve postpartum emotion regulation, newborn neurobehavior, and mother-infant co-regulation. Early identification of the mechanisms implicated in risk. The researchers will deliver 10 weeks of DBT skills classes selected and adapted to meet the unique needs of pregnancy (DBT-P). The goal of this work is to improve perinatal mental health trajectories. The premise of this study-that improving emotion regulation in pregnancy may disrupt intergenerational transmission of psychopathology-is informed by our research over the past two decades, including several NIH awards (R01MH119070, R01MH132210, R01DA049755, R21MH1090777, F31MH074196). The investigator' data reveal that maternal emotion dysregulation confers risk for mother. The research also shows that resting respiratory sinus arrhythmia (RSA), a physiological index of emotion dysregulation, can be improved via intervention in non-pregnant adults. The investigators propose that DBT-P will increase emotion regulation skills use or increase RSA in the mother (target engagement) leading to significant reductions in her emotion dysregulation prior to birth. The primary study objectives are to recruit 100 pregnant women with high emotion dysregulation to receive either: (1) dialectical behavior therapy skills groups or an Assessment only control; and (2) to evaluate whether the treatment improved emotion regulation skills use as well as respiratory sinus arrhythmia.

Conditions

• Emotion Dysregulation

Interventions

Type	Name	Description
BEHAVIORAL	Moms2B	An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
BEHAVIORAL	DBT-P	An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.

Timeline

• Start date: 2025-06-06
• Primary completion: 2026-10-05
• Completion: 2026-10-19
• First posted: 2025-05-09
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States